BEUDAMED
    FDA PMA 30-Day Notice Accepted 🇺🇸 United States

    PMA: P980001 · Supplement: S029 · Decision Mar 27, 2001
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    NIR(R) PREMOUNTED STENT DELIVERY SYSTEMS
    PMA Number
    P980001
    Supplement Number
    S029
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    March 27, 2001
    Date Received
    February 27, 2001
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE FROM AN INTERNAL PARTICULATE MAXIMUM LEVEL TO AN INTERNAL PARTICULATE ACTION LEVEL OF 75,000 PARTICLES >=10 MICRONS FOR THE FINISHED PRODUCT.